The U.S. District Judge presiding over all federal DePuy ASR hip lawsuits has ordered plaintiffs who have not yet required revision surgery to make a decision about how they will proceed with their case, as DePuy Orthopaedics continues to only settle claims for problems resulting in revision and has offered to toll the statute of limitations in other cases until any future surgery is needed.

Earlier this week, it was reported that the device manufacturer is prepared to offer another $250 million in DePuy ASR settlements to resolve an additional 1,000 revision cases that did not qualify for the original deal.

In an order (PDF) issued on October 30, U.S. District Judge David A. Katz ordered all non-revised plaintiffs with claims pending in the federal court system to elect whether they intend to continue with their case at this time, or dismiss the case without prejudice, which would allow them to refile the lawsuit in the future if they require revision surgery.

DePuy has offered to enter into a tolling agreement with any non-revision plaintiffs, which will “pause” running of any deadlines on filing new lawsuits in return for a dismissal of the current claim and agreement not to refile the case until hip revision surgery is required or they are told that they are unable to undergo the risks of revision surgery due to their underlying medical condition.

Under terms of the agreement, plaintiffs who elect to dismiss their case may refile within one year after they receive ASR hip revision surgery in the future or within six months of being told that revision surgery is necessary, but too risky.

If non-revised plaintiffs elect not to dismiss their case at this time with tolling, Judge Katz indicates that discovery will move forward immediately, which may make the cases subject to motions to dismiss by DePuy over whether they have a viable case at this time, prior to experiencing problems that resulted in the need for additional surgery.

Hip Replacement Settlements

More than 12,000 DePuy ASR hip cases were filed prior to the original settlement, but it is estimated that 90,000 of the implants were sold world-wide before the design was recalled in August 2010.

The DePuy ASR recall was issued after the manufacturer acknowledged that a higher-than-expected number of the metal-on-metal hip implants were failing within a few years after surgery. While original estimates suggested that about one out of every 8 may fail within five years, subsequent data suggests that the DePuy ASR failure rate may be substantially higher.

The metal-on-metal design features a metal femoral head that rotates within a metal acetabular cup, resulting in the release of metallic debris as the parts rub against each other during normal daily activities. The lawsuits allege that this debris causes metal blood poisoning, known has hip metallosis, with can lead to the loosening and ultimate failure of the artificial hip.

Under terms of the original DePuy settlement, Johnson & Johnson agreed to pay about $250,000 for each hip patient who required replacement of an ASR hip at least 180 days after it was implant, with several factors that may increase or decrease the individual award. In addition, the medical device manufacturer agreed to directly cover medical costs associated with hip problems.

A similar deal was announced this week to settle Stryker hip replacement lawsuits, resolving several thousand cases brought by individuals who required revision surgery after receiving the recalled Rejuvenate or ABG II modular hip system.

Unlike traditional hip implants, which feature a single femoral component, the Stryker Rejuvenate and ABG II hops featured modular neck stem, with two pieces that fit inside of each other to allow the surgeon to customize the length of the component based on the patient.

As the metal pieces in the modular stem rub against each other, they have also been found to release microscopic debris, which may cause the implant to fret, corrode and ultimately fail. More than 4,000 Stryker Rejuvenate lawsuits have been filed to date, but an estimated 20,000 were implanted before the recall. Therefore, it is also expected that additional cases and settlements will be announced as Stryker Rejuvenate hips fail in the future and result in the need for revision surgery.